Phase IIIb Study to Evaluate the Effectiveness and Safety of Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in Human Immunodeficiency Virus (HIV)-Infected Subjects Evidencing Virologic Suppression (OREY)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00337467
First received: June 14, 2006
Last updated: June 18, 2010
Last verified: June 2010
Results First Received: May 21, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus (HIV) Infections
Intervention: Drug: Atazanavir + Ritonavir

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
63 participants were enrolled in this study; 2 were never treated (1 no longer met study criteria and 1 concomitant medication not permitted).

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy. ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Participant Flow:   Overall Study
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.  
STARTED     61  
Discontinued Prior to Week 96     10 [1]
COMPLETED     51  
NOT COMPLETED     10  
Adverse Event                 3  
Subject Withdrew Consent                 2  
Pregnancy                 1  
Lost to Follow-up                 2  
Subject No Longer Met Study Criteria                 2  
[1] 5 of these participants discontinued prior to Week 48



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy. ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Baseline Measures
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.  
Number of Participants  
[units: participants]
  61  
Age  
[units: years]
Mean ± Standard Deviation
  43  ± 9.5  
Gender  
[units: participants]
 
Female     15  
Male     46  
Race/Ethnicity, Customized  
[units: participants]
 
White     61  
Cluster of Differentiation 4 (CD4) Categories  
[units: participants]
 
CD4 Count <200 cells/mm3     3  
CD4 Count >=200 cells/mm3     58  
Human Immunodeficiency Ribonucleic Acid (HIV RNA) Categories  
[units: Participants]
 
HIV RNA <50 c/mL     60  
HIV RNA >=50 c/mL     1  
CD4 Count  
[units: cell/mm3]
Mean ± Standard Deviation
  559  ± 272.8  
Fasting High-Density Lipoprotein (HDL) Cholesterol [1]
[units: mg/dL]
Mean ± Standard Deviation
  45  ± 10.4  
Fasting Low-Density Lipoprotein (LDL) Cholesterol [1]
[units: mg/dL]
Mean ± Standard Deviation
  112  ± 52.3  
Fasting Non-HDL Cholesterol [1]
[units: mg/dL]
Mean ± Standard Deviation
  144  ± 57.9  
Fasting Total Cholesterol [1]
[units: mg/dL]
Mean ± Standard Deviation
  189  ± 57  
Fasting Triglycerides [1]
[units: mg/dL]
Mean ± Standard Deviation
  164  ± 95.7  
HIV RNA  
[units: log10┬ác/mL]
Mean ± Standard Deviation
  1.71  ± 0.152  
[1] Population analyzed = 54 (treated participants with baseline measure)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Treatment Failure Through Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   Percentage of Participants With Treatment Failure Through Week 96   [ Time Frame: Week 96 ]

3.  Secondary:   Percentage of Participants With Virological Rebound Through Week 48   [ Time Frame: Week 48 ]

4.  Secondary:   Percentage of Participants With Virological Rebound Through Week 96   [ Time Frame: Week 96 ]

5.  Secondary:   Cumulative Proportion of Participants Without Treatment Failure Through Week 100   [ Time Frame: Through Week 100 ]

6.  Secondary:   Proportion of Participants With Virologic Rebound Through Week 96   [ Time Frame: Through Week 96 ]

7.  Secondary:   Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24   [ Time Frame: Baseline, Week 24 ]

8.  Secondary:   Mean Change From Baseline in CD4 Cell Count at Week 48   [ Time Frame: Baseline, Week 48 ]

9.  Secondary:   Mean Change From Baseline in CD4 Cell Count at Week 96   [ Time Frame: Baseline, Week 96 ]

10.  Secondary:   Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs   [ Time Frame: From Baseline through Week 96 ]

11.  Secondary:   Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48   [ Time Frame: Baseline, Week 48 ]
  Hide Outcome Measure 11

Measure Type Secondary
Measure Title Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Measure Description Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.
Time Frame Baseline, Week 48  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
n= number of treated participants with baseline measure and measure at Week 48

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy. ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Measured Values
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.  
Number of Participants Analyzed  
[units: participants]
  61  
Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48  
[units: percent┬áchange]
Mean ± Standard Deviation
 
Total Cholesterol (n=36)     9  ± 18.0  
HDL Cholesterol (n=35)     2  ± 18.5  
Non-HDL Cholesterol (n=35)     12  ± 24.4  
LDL Cholesterol (n=33)     20  ± 33.4  
Triglycerides (n=36)     17  ± 51.4  


Statistical Analysis 1 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 9
Standard Error of the mean ± 3.0
95% Confidence Interval ( 2.5 to 14.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting Total Cholesterol at Week 48
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 2
Standard Error of the mean ± 3.1
95% Confidence Interval ( -3.9 to 8.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting HDL Cholesterol at Week 48
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 12
Standard Error of the mean ± 4.1
95% Confidence Interval ( 4.0 to 20.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 48
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 20
Standard Error of the mean ± 5.8
95% Confidence Interval ( 8.0 to 31.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting LDL Cholesterol at Week 48
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 17
Standard Error of the mean ± 8.6
95% Confidence Interval ( -0.4 to 34.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting Triglycerides at Week 48
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



12.  Secondary:   Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96   [ Time Frame: Baseline, Week 96 ]

13.  Secondary:   Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48   [ Time Frame: Week 48 ]

14.  Secondary:   Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96   [ Time Frame: Week 96 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information